PCO2 ELSO (Extracorporeal Life Support Organization)

March 12, 2021 updated by: Nantes University Hospital

Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns

Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.

Study Type

Observational

Enrollment (Actual)

4072

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates (<28 j) supported by ECMO for severe respiratory failure

Description

Inclusion Criteria :

  • Support by ECMO for respiratory indication

Exclusion Criteria :

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Neurological Event
Time Frame: Up to 90 days after ECMO initiation

Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item:

  • Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI
  • Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG)
  • Brain death clinically diagnosed
Up to 90 days after ECMO initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days after ECMO start
Newborns died after 28 days despite ECMO assistance
28 days after ECMO start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

December 11, 2020

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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